Facility

HAAG-STREIT UK LTD.

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004950803
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	Unit C, Woodside, Woodside Industrial Estate Bishop's Stortford Hertfordshire, GB CM23 5RG
Registration status	Active · expires 2026
Parent company	HAAG-STREIT HOLDING (owner-operator 8031066)
Brand names	TNO STEREOTEST C/W SPECTACLES; CAT STEREOGRAMES; FRISBY STEREOTEST; LANG STEREOTEST NO.1 IN WALLET; 123 STEREOGRAMS PER PKT 0F 100; VARIOUS STERO TEST; OPEN BUCKET STEREOGRAMS

Activity by year

Recalls (6)
Inspections (1)

Devices registered here (1)

Instrument, Measuring, Stereopsis
Product code HLC (opens in a new tab) · Class I · Ophthalmic · 21 CFR 886.1460

Recalls & enforcement

Class IIOngoing2021-11-03
Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
Class IIOngoing2021-04-15
Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
Class IIOngoing2020-11-20
Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered by pressing the button of the footswitch it might occur that the movement does not stop when releasing the button, result in potential risk to the patient's eye
Class IITerminated2019-07-31
software error in the central control unit of the floor stand.
Class IITerminated2017-01-05
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Class IITerminated2012-08-17
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

FDA inspections (1)

NAI2018-06-14
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HAAG-STREIT UK LTD. (FEI 3004950803) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004950803-haag-streit-uk-ltd/

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